January 2022

HSA update guidance on medical device product registration GN-15

HSA issues updated guidance on Medical Device Product Registration (GN-15)

The Singapore Health Sciences Authority (HSA) has updated regulatory Guidance GN-15 on Medical Device Product Registration to expand the types of approvals from the following reference regulatory agencies: For Class B Medical Devices, the updated reference agencies’ approval types include: The US Food and Drug Administration (US FDA) De Novo European Union Notified Bodies (EU …

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HSA issues updated guidance on Grouping of Medical Devices for Registration

HSA issues updated guidance on Grouping of Medical Devices for Registration

The Singapore Health Sciences Authority (HSA) has issued updated Guidance on the Grouping of Medical Devices for Registration (GN12-2 revision 2). This concerns:   Dental Medical Devices of Class B only which wish to apply for registration using dental grouping terms. Applicants may group their dental devices using GN-12-1 or this latest version of the …

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MDA Guideline on Registration of COVID-19 Test Kits

MDA Guideline on Registration of COVID-19 Test Kits

The Malaysian Medical Device Authority (MDA) released a new Guideline for the Registration of COVID-19 IVD Test Kits (MD/GL/07) on 24 January 2022. The guideline covers both the registration of COVID-19 test kits for those kits which have previously obtained Special Access Notification or Conditional Approval. It also covers registration for new COVID-19 test kits …

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mda announces end special access routes covid19 test kits

Malaysian MDA announces end of Special Access Route for COVID-19 Test Kits

The Malaysian Medical Devices Authority (MDA) has decided that all COVID-19 test kits whether for professional use or for personal use must be registered under Section 5 of the Medical Devices Act 2012 (Act 737) before being placed on the market. This is effective as of 1 February 2022. This means that as from 31 …

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Draft guidelines categorization of borderline health products FDA Philippines

FDA Philippines issues draft guideline on categorization of borderline health products

The Food and Drug Administration Policy and Planning Service (FDA PPS) of the Philippines has issued draft guidelines for comments and input from industry stakeholders covering the categorization of borderline health products under the jurisdiction of the FDA. The FDA’s jurisdiction covers multiple product categories such as devices, cosmetics, drugs, food, and others. Some health …

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in vitro diagnostic draft regulation fda philippines

FDA Philippines issues draft regulation on IVD market authorizations

The Food and Drug Administration (FDA) of the Philippines has issued a draft regulation on IVD market authorizations. The draft is open for comments from industry stakeholders until 7 February 2022. Here are the main points of the draft regulation issued by the FDA: New registration, notification and listing certificates specially for In-Vitro Diagnostics will …

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Philippines FDA allows registration Covid19 Self Test Kits

Philippines FDA opens registration to COVID19 Self-Test Kits

The Philippines FDA now accepts applications for registration for COVID 19 Self-Test Kits. The Philippines FDA issued Advisory No. 2021-3604 on 29 December 2021 regarding the start of acceptance of submissions for Special Certification of COVID-19 self-test kits that will be effective as of 6 January 2022, in accordance with the following Memorandums: FDA Memorandum No. …

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Restrictions online selling optical devices and contact lenses in Malaysia

Restrictions for the selling of Optical Devices and Contact Lenses online in Malaysia

Restrictions for the selling of optical devices and contact lenses online in Malaysia were announced by the Medical Device Authority (MDA) on 7 January 2022. This announcement prohibits the online sale of optical devices or contact lenses on any e-marketing platform except for websites (managed by Registered Optometry Practitioners) that must meet strict guidelines issued …

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Covid 19 Test Kit Philippines Validity Extension

COVID-19 Test Kit in the Philippines: ‘authorization validity’ extension

The Food and Drug Administration (FDA) of the Philippines has issued an amendment to FDA Circular No. 2021-023 extending the current validity of market authorizations, Special Certification, for COVID-19 Test Kits, from 31 December 2021 to 31 January 2022. This extension is valid ONLY for COVID-19 Test Kits whose marketing authorization holder applied for re-issuance …

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